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To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.

The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.

Spire Biomedical Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ are radiopaque silicone catheters that have been coated with silver using a physical vapor deposition process. The silver is applied to the distal end of the catheter from approximately 2-5mm below the cuff to the tips, and is on the exterior surfaces of the catheter only. Aside from the silver coating, the catheters have identical physical characteristics to the non-coated RetrO and XpressO catheters, both of which have 510(k) Premarket Approval. The catheter configurations (available lengths and insertion kit components) are also identical. The silver coating is applied by a vacuum-based physical vapor deposition process called ion beam assisted deposition (IBAD). IBAD combines evaporation with concurrent ion beam bombardment. The process is performed under a high vacuum environment. A silver vapor is formed via electron beam evaporation and deposited onto the catheter. Simultaneously, energetic ions bombard the catheter surface and coating as it is deposited. The coating consists of three layers: titanium, palladium, and silver. The film layers are deposited sequentially with the titanium and palladium layers being completely covered by the silver.

Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated). The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.

The 55cm 15.5Fr Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

55cm 15.5Fr Decathlon™ carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.

The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm. The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™. The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.

Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO catheters.

Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO Twin Lumen Silicone Hemodialysis Catheters with Separated Tips.

Percutaneous insertion kit designed to provide physicians with a dual wire technique for use with Spire Biomedical, Inc.'s Pourchez XpressO™ and Pourchez RetrO™ catheters only.

The "SafeTrac Dual Wire Insertion Kit" provides an alternative method for chronic hemodialysis catheter placement by using an over the wire technique dilating and inserting either the Pourchez RetrO and XpressO catheters over a guidewire percutaneously. The introducers consist of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist dilation. The hub proximal end has a female luer lock configuration. An optional hub collar may be used to attach the dilator to the catheter. The kits come with two quidewires, two 5F dilators, a 6F, 14F and 16F sheath/dilators in five different lengths. Each kit consists are to be supplied sterile and for single use only. The kits are to be sold in boxes of five.